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Tibial Fractures clinical trials

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NCT ID: NCT06337292 Not yet recruiting - Wound Heal Clinical Trials

Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial

iVAC
Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision >3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome.

NCT ID: NCT06293469 Not yet recruiting - Clinical trials for Extremity Fracture Lower

Accelerated Flap Coverage in Severe Lower Extremity Trauma

FLAP ATTACK
Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).

NCT ID: NCT06288139 Not yet recruiting - Open tíbia Fracture Clinical Trials

Management of Open Fracture Tibia in Teenagers

Start date: March 1, 2024
Phase:
Study type: Observational

The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes

NCT ID: NCT06280417 Not yet recruiting - Tibia Fracture Clinical Trials

Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults

Start date: June 1, 2024
Phase:
Study type: Observational

To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome .

NCT ID: NCT05766670 Not yet recruiting - Tibial Fractures Clinical Trials

Intramedullary Calcium Sulfate Antibiotic Depot

Start date: May 2024
Phase: Phase 3
Study type: Interventional

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

NCT ID: NCT05652881 Not yet recruiting - Tibial Fractures Clinical Trials

Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?

Start date: January 2023
Phase: N/A
Study type: Interventional

High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.

NCT ID: NCT05501496 Not yet recruiting - Fracture of Tibia Clinical Trials

Conservative Versus Intramedullary Nailing for Pediatric Tibial Shaft Fractures

CINPED
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Tibial shaft fracture is a common fracture in the pediatric and adolescent population. The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment. The investigators will conduct a multicenter, randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis.

NCT ID: NCT05459038 Not yet recruiting - Surgery Clinical Trials

Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.

Start date: September 2022
Phase: N/A
Study type: Interventional

Tibia shaft fractures are common long bone fractures in the field of Orthopaedic Trauma. In the USA, a total of 492.000 tibial fractures were reported per year by the National Center of Health Statistics (NCHS). Intramedullary nailing (IMN) is the treatment of choice for shaft fractures. However, rotational malalignment (RM) remains an iatrogenic pitfall with a prevalence up to 30%. From a clinical point of view, there is limited knowledge on how to avoid RM during IMN. Clinical estimation of tibial alignment is difficult, resulting frequently in RM following IMN. Low-dose CT-assessment is considered the gold standard to objectify RM, but is performed after surgery when the opportunity for direct revision has passed. Both difficulties in intraoperative clinical judgement of tibial alignment as well as postoperative detection of RM when the possibility for direct revision has passed, do support the need for an easy-to-use intraoperative fluoroscopy protocol to minimize the risk for RM during IMN of tibial shaft fractures. Recently, a standardized intraoperative fluoroscopy protocol named the 'C-Arm Rotational View (CARV)' was determined in order to improve the accuracy of alignment control during IMN of tibial shaft fractures. CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used. Promising preliminary results were found to reduce the risk on RM following IMN of tibia fractures. However, a prospective trial is needed to determine the performance of CARV in clinical practice. Therefore, a prospective multi-center randomized controlled trial is designed to assess the clinical feasibility and potential benefits of the CARV-protocol. The following primary research question was defined: can the risk for RM following IMN of tibial shaft fractures be minimized by use of the CARV-protocol?

NCT ID: NCT05435261 Not yet recruiting - Fractures, Open Clinical Trials

Ganga Hospital Scoring System In Type-IIIA/B Open Tibial Fractures

Start date: December 1, 2022
Phase:
Study type: Observational

The aim of this study is to assess interobserver reliability, sensitivity for amputation, and specificity for salvage of GHS in type-III injuries with open tibial fractures and predict the potential number of inpatient days, secondary procedures that would be required, and the rate of infection

NCT ID: NCT04072094 Not yet recruiting - Open tíbia Fracture Clinical Trials

Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture

Start date: June 2020
Phase: N/A
Study type: Interventional

The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.